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CDRH Compliance Consulting for Laser Products


CDRH Compliance Consulting for Laser Products

We offer CDRH Compliance Consulting services for customers who seek guidance in certification of their new laser or laser system with the Center for Devices and Radiological Health (CDRH).

The purpose of this self-certification is to assure that a laser product is complient with CDRH's laser safety requirements. Consequently, CDRH's approval of certification gives manufacturer a permission to use, sell, or distribute the laser in the US market.

The standards for CDRH laser certification are known as Federal Laser Product Performance Standards (FLPPS).

We employ a team of experienced Certified Laser Safety Officers (CLSOs) to provide CDRH consulting for customers in manufacturing, building/construction, education, R&D, health care, and entertainment.


Consulting Process

To help you self-certify your laser product we assign a CLSO to you to guide you through the certification process. The project is typically accomplished in fives steps:

  • Step One - Project Planning/Estimate Development With the Customer
    • CLSO and the customer work out the certification scope (i.e. number of lasers to be certified, time table for the project, etc.) A purchase order (PO) is signed and system design review and audit is scheduled.
  • Step Two - System Design Review and Audit by CLSO
    • CLSO performes a complete System Design Review and Audit (at customer's facility, if needed) to determine each laser's classification given system's accessible emission limits (AELs) during normal operation. In addition, CLSO gathers qualitative data on protective housing, safety interlocks, remote interlock connector, key control, user information, and other to fulfill compliance requirements.
  • Step Three - System Design and Audit Analysis by CLSO and Development of the 1st DRAFT with the Customer
    • CLSO evaluates the data generated from the System Design Review and Audit and provides recommendations on the findings to the customer.
    • Given CLSO's analysis and recommendations, CLSO and customer work together to create the 1st DRAFT of the document. Phone conversations, email messaging, exchange of files, CAD drawings, schematics, etc. are all part of this stage.
  • Step Four - Development of the FINAL DRAFT with the Customer
  • Step Five - Customer Files a Mutually Approved FINAL DRAFT with the CDRH

Because each certification case is unique, we don't have a standard timeline for the completion of this service. For that reason we work very carefully with the customer on the first step of the consulting process (i.e. Project Planning) to account for all project's deadlines.

Here is an Example of an Estimate for CDRH Compliance Consulting by Laser Safety Academy.

Estimate

To learn more about Laser Safety Academy's CDRH consulting process or to get an estimate, please email, chat online, or call one of our CLSOs - 651-357-1800.




Online Laser Safety Training

Other Services

In addition to CDRH Compliance Consulting, Laser Safety Academy offers workplace Laser Safety Audits, Laser Safety Training, and Medical Laser Safety Training.